RecruitingNCT01420562

Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

55 participants

Start Date

Sep 1, 2011

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • Patients receiving allogeneic stem cell transplantation - Treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections

Exclusion Criteria4

  • Gastroparesis
  • Vomiting or diarrhea within 2 hours after intake of posaconazole
  • Concomitant administration of potent inducers of the enzyme UGT1A4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,...
  • Age under 18 years

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Interventions

PROCEDUREblood sampling

During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.


Locations(1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

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NCT01420562


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